Analysis of the Toxicity and Efficacy of Daily 1 vs 2 Beam Proton Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Antoine Lacassagne
About this trial
Thanks to the intrinsic qualities of the proton beam, proton therapy will reduce adverse effects of irradiation. The Proteus®One is the latest generation of proton therapy equipment, enabling the Centre Antoine Lacassagne to expand its range of treatments by carrying out new proton therapy treatments. It has an innovative compact isocentric rotating head (Gantry) that allows the radiation beam to be directed at different angles around the patient. In some cases, two beams are used to treat tumours, and by convention, both beams are delivered during the same session. However, it is necessary to position the patient before each beam, which is time-consuming because 2 beams have to be positioned very precisely each day. The aim of this study is therefore to assess the toxicity of proton therapy delivered by a single daily beam compared with proton therapy delivered by two daily beams, which is the conventional technique.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chordoma, chondrosarcoma of the skull base and spine, Ewing's sarcoma, and osteosarcoma meeting the criteria for treatment by proton therapy
Tumour requiring 2 beams
MRI less than one month old
PS 0-2.
Disqualifiers
Persons deprived of their liberty or under guardianship.
Unable to undergo the medical follow-up of the clinical investigation for geographical, social or psychological reasons.
Patient eligible for symptom reduction surgery Vulnerable populations and participants defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
Trial design
Design model
Parallel
Treatments tested in this trial
Proteus ONE one daily beam
RadiationA single daily beam is used, doubling the dose delivered for this treatment incidence.
Proteus ONE two daily beam
Radiationtwo daily beams are used, in accordance with the initial treatment plan and the patient's standard of care
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: 1DBExperimental treatment 1 intervention
Group B: 2DBActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the frequency of occurrence of toxicities in the group of patients treated with two daily beams (2DB) and in the group of patients treated with one daily beams (1DB).
Assessment of the incidence of grade ≥2 medical device-related toxicities assessed according to CTCAE version 5.0 in each of the two treatment arms.
Time frame
During 2 to 7 weeks of protontherapy treatment and during 5 years follow-upSecondary outcomes
1
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of relapse rate
Time frame
5-year follow-up visits2
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of local control by MRI assessment
Time frame
5-year follow-up visits3
Determining the effectiveness of proton therapy
Efficacy will be assessed in terms of overall survival
Time frame
5 years follow-up4
Quality of life assessment
Quality of life will be assessed using the EORTC QLQ-C30 scale (Appendix 2), version 3 at the inclusion assessment, at the end-of-treatment visit and at each assessment visit for five years. Version 3.0 of the QLQ-C30 has four-point scales for the items 1 to 28 namely : 1 : "Not a tall", 2 : "A little", 3 : "Quite a bit" and 4 : "Very much." Higher score mean worse outcome. Item 29 and 30 has seven-point scales from 1 : " very bad " to 7 "Excellent". Lower score mean worse outcome.
Time frame
During 2-7 weeks of protontherapy treatment and during 5 years follow-upSponsors and contacts
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Source ClinicalTrials.gov